Bio-sensor

ABSTRACT

A bio-sensor strip adapted to be located between an object and a body part. The bio-sensor strip comprises one or more of bio-sensors ( 819, 919 ) disposed on at least one first polymer film ( 825 ), wherein the bio-sensors ( 819, 919 ) measure parameters at a location between the object ( 216, 316, 916 ) and the body part ( 932 ).

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to and benefit of Luxembourg PatentApplication No. LU 100021 filed on 13 Jan. 2017.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to improvements in relations to systems,apparatus and methods of measuring and adapting objects for acomfortable engagement with an engaging member, and more particularly toa bio-sensor strip attached an object, a body part or a liner over thebody part, to measure parameters between the object and the body partand thus aid in achieving a comfortable and functional fit between theobject and the body part. Examples of the objects include prostheses andorthoses, for example the fitting of a prostheses to a stump of theresidual limb of a wearer.

Brief Description of the Related Art

The fitting and shaping of the socket of an artificial limb (prosthesis)to ensure that the artificial limb is an accurate fit with the stump ofthe residual limb with which the artificial limb engages is one of themost important parts of or in the formation of a prosthesis, and alsoone of the most difficult. The socket serves as an interface between theresidual limb and the prosthesis, allowing comfortable weight bearing,movement, and balance. The socket therefore has to be shaped to be aperfect fit, with an adequate or desired surface bearing or loading toprevent painful points of contact. Pain and discomfort may occur frompressure, friction, temperature, or any other physical situation causedby an improperly fitted socket or a misaligned prosthesis. It will beappreciated that friction will lead to an increase in temperature andthis can be measured by temperature sensors.

At the same time, the socket needs to be sufficiently tight so thatduring movement the prosthesis is firmly held in place and does not falloff or twist. The prosthesis also needs to be adjustable to take intoaccount that the volume of the residual limb changes over time. Forexample, in the first few months after amputation, the stump of theresidual limb will change in shape due to changes in fat and muscledistribution.

Currently, in order to make a new prosthesis to fit the stump, a mouldof the stump is first taken, and the socket of the prosthesis is shapedaccording to the shape of the mould, and this shaping process is eithermanual or executed by a machine under computer control, or a combinationof both. Once this rough shaping is completed, the shape of the socketis then fine-tuned, usually manually, to create a comfortable fit withthe stump. However, prior art methods of fine-tuning of the shape of thesocket to create a comfortable fit to a stump are laborious, empiricaland time consuming. The shaping process relies fundamentally on verbalfeedback from the wearer with regard to how the prosthesis feels, wherethe prosthesis is rubbing and the like. Small changes are then made andthe fit tried again. Such communication is, however, often imprecise andvery simple, with the patient simply indicating generally wherediscomfort or pain is occurring on the stump. This is made moredifficult by the fact that firstly, the nature of the pain or discomfortis that the pain or discomfort usually does not just occur at the pointof contact but in an area around the point of contact, so that locatingthe issue point precisely is very difficult. Secondly, the patient mayhave to remove the stump from the socket in order to identify the painpoint, and once so removed, the pain will tend to soften, again makingit more difficult to accurately identify the actual contact point.Moreover, the trauma or the pathology that led to limb loss may itselfhave caused nerve displacement, so that the place where pain is felt(pain point) and the actual friction or pressure spot may be in twodifferent locations, or have caused reduced sensitivity, so that thepatient is unable to give precise information. Furthermore, thepsychological trauma or indeed general reluctance of the patient toprovide detailed feedback may lead to incorrect or impreciseinformation. The phenomenon of “phantom limb pain” is also known thatwill also affect the information provided to a fitting technician by thepatient.

There is therefore a need for a system that is able to provide precise,objective and location-specific information about the fit between aresidual limb stump and a prosthetic socket.

In an attempt to improve on the prior art approach, U.S. PublishedPatent Application No. 2014/0063220 discloses a photo-based fittingsystem in which the patient's residual limb is photographed from manyangles to provide a spatial image of the residual limb and facilitatethe design and construction of the prosthetic socket. However, thisapproach does not provide any information on the comfort of the fitbetween the stump and the socket once the socket has been formed, andreally only provides an alternative to taking a mould of the stump forthe rough forming of the socket. There is no teaching provided as to howto better fine tune to the fit between the stump and the socket.

Similarly, WO 2014/036029 discloses a viewfinder based system foracquiring data on the stump for which a prosthetics socket needs to bebuilt, but again this does not provide any teaching regarding the finetuning of the socket to ensure a comfortable fit. It should also benoted that in both cases, the information provided is static and refersto a moment in time, when the photograph was taken and ignores anydynamic data produced during actual continued use of the prosthesis.

U.S. Pat. No. 8,784,340 discloses a further solution to the problem offitting a prosthetic limb in which a liner is fitted over the stump, theliner having a plurality of pressure sensors embedded therein which areconnected to a data acquisition system. However, this solution does notprovide any teaching as to how the technician can use the collected datato improve the shape of the socket as the pressure sensors does notprovide any precise spatial information which can be used to correlatethe pressure data with the shape of the socket. This is made worse bythe fact that the liner is fitted to the stump, so at least the linercould only provide information on the shape of the stump rather than thesocket, and in any event, due to the nature of the liner and itsimprecise fitting, the exact location of the sensors on the stump cannotbe ascertained in that system. Finally, in the absence of any adhesivelayer or securing mechanism, the liner cannot be prevented fromcontinuously moving, thereby providing incorrect data.

Similarly, U.S. Pat. No. 5,993,400 teaches an apparatus and method formonitoring pressure between the surface of a body part (residual limb)and a contact surface on, for example, a prosthetics socket, a bed or awheelchair. This apparatus and method employ a plurality of pressuresensors disposed in a matrix array between the contact surface and thebody part. The sensors produce analog force signals proportional topressure, and a monitor receives the analog signals and produces outputsignals, preferably digital, having pressure data corresponding to thepressure at each sensor. A computer processor receives the outputsignals from the monitor to create a force profile for the sensor array.The sensors may be scanned as a read event in variety of manners,including periodic, continuous, and triggered scanning. This monitoringapparatus and method is used, for example, to fit prosthetics, tomonitor bed-ridden and wheelchair-bound patients, to reduce pain andsores caused by uneven distribution of pressure and to monitor pressurebetween a cast and a person. The sensors may be mounted on a singlesheet or on strips for positioning along the body, and monitoring isaccomplished by multiplexing and digitizing the analog force signals.

A number of patent documents are known that teach the design andmanufacture of prosthetic sockets using computer aided design. Forexample, International Patent Application No. WO 2012/083030 teachesabove knee (AK) and below the knee (BK) prosthetic sockets and specificmanufacturing processes for the production of prosthetic sockets throughthe automated, computer controlled bi-axial and tri-axial braiding ofsockets, over a mold or mandrel made of carved foam, plaster material orwax that is a replica of the patient's truncated limb, and is created bya Computer Aided Design (CAD) file controlling a Numerically Controlled(CNC) machine tool. The prosthetic sockets are manufactured using fiberssuch as graphite or Kevlar, and high-performance resins, and create asocket which is stronger and lighter weight than conventionallymanufactured sockets. Braiding also allows incorporation of woven cloth,tapes and other reinforcements into the braiding process for addedstrength at selected areas.

U.S. Published Patent Application No. 2010/0023149 teaches a method forevaluating prosthetic sockets (and other objects) which are designed andfabricated with computer aided design and manufacturing software. Theshape of the prosthetic socket is accurately scanned and digitized. Thescanned data are then compared to either an electronic shape data file,or to the shape of another socket, a positive model of a residual limb(or socket), or a residual limb. Any differences detected during thecomparison can then be applied to revise the design or fabrication ofthe socket, to more accurately achieve a desired shape that properlyfits the residual limb of a patient and can be used to solve the inverseproblem by correcting for observed errors of a specific fabricatorbefore the prosthetic socket is produced. The digitizing process isimplemented using a stylus ball that contacts a surface of the socket toproduce data indicating the three-dimensional shape of the socket.

SUMMARY OF THE INVENTION

There is a need for a system and method for providing parametersconcerning the interaction between a body part and an object, to enablefor example the fine tuning of the shape of the socket to fit the stumpby providing precise information on the mismatching between the shape ofthe socket and the shape of the stump. More generally, one or morebio-sensor strips is provided that can be used for identifyingdifference in shape, load and biosensor profile distribution, as well asthe physical characteristics between an object, a body part, i.e. partof a human body, or a liner-covered body part, which is engageable withthe object.

The bio-sensor strip of this document is adapted to be located betweenan object and a body part and comprises one or more of bio-sensors thatare disposed on at least one first polymer film. The bio-sensorsevaluate properties by measuring parameters at a location between theobject and the body part. A plurality of power leads and data leads areconnected to the plurality of bio-sensors and to a power and dataconnector and are adapted to transfer data from the plurality ofbio-sensors to a processor. The data transfer can be along leads orfibre-optic cables or can be wirelessly transferred. The bio-sensors canrecord not only parameters at the locations, but also in some case moregeneral parameters, such as the pulse or heart rate, which are notlocation-dependent. The bio-sensors can be arranged in a single strip orin an array.

In one aspect, a body part liner is disposed between the bio-sensorstrip and the body part but the bio-sensors are still thin enough tomeasure parameters at this location.

The bio-sensor strip may have a second polymer film disposed on anopposite side of the one or more bio-sensors and the plurality of powerleads and data leads to sandwich or encapsulate the bio-sensors.

The bio-sensor strip has one or more markings disposed on one side whichare used to determine the location of the bio-sensor strip. A side ofthe bio-sensor strip in contact with the body part or the body partliner is made in one aspect from polyurethane and the side of thebio-sensor strip in contact with the object is made in one aspect fromsilicone.

The one or more bio-sensors measure at least one of pressure between thebody part and the object, temperature or humidity at the location, orcan be used to measure at least one of a pulse or a galvanic response.The galvanic response is indicative of the humidity which will becaused, for example, by sweating or condensation. These parameters are,however, not limiting of the invention.

A method of evaluating properties between a body part and an object isalso disclosed in this document. The method comprises affixing one ormore the bio-sensor strips to one of the body part, a liner covering thebody part or the object, collecting data from the one or more bio-sensorstrips, and processing the data from the one or more bio-sensor stripsto produce a heat map of the properties between the body part and theobject. These properties are indicative of one of fit, interaction ordynamics between the body part and the object.

In one aspect of the method, the recording of the data from the one ormore bio-sensor strips is carried out whilst the body part is in motion.This data can be combined with data from a motion sensor and correlatingthe data from the motion sensor with the data from the one or morebio-sensor strips.

It will be noted that the bio-sensors may also be attached to the bodypart but what is important is that they are firmly positioned and heldin place between the object and the body part.

The one or more bio-sensors can be of different types and include, butnot limited to, one or more of pressure sensors, temperature sensor,accelerometers, magnetometers, pedometers, galvanic response sensors,humidity sensors, air flow sensors, electromyography sensors,electrocardiography sensors, oximetry sensors and mechanomyographysensors. Preferably the sensors include a plurality of pressure andtemperature sensors. The pressure sensors measure forces at the normalto the surface of the body part, whilst the temperature sensors indicatefriction between the body part and the object due to transverse forcesalong the surface of the body part.

The body parts can be, for example, a stump of an amputated limb, alimb, a bottom sitting on a wheelchair, a back lying on a bed. Theobjects are in these examples a socket for a prosthesis, an orthoticelement, e.g. knee brace, a wheelchair, or a bed. It will be appreciatedthat the invention has other applications.

A method and apparatus according to the invention has the advantage thatby mapping the bio-data onto the socket surface map, the prosthesisfitting technician is provided with an accurate guide of where issuesexist at the interface between the stump and the socket, and thereforemakes identification of the regions of the socket which need adapting,rectifying, tuning or shaping and the amount required thereof mucheasier. As a result, the number of iterations to achieve a good fit isreduced resulting in a shorter, more efficient, and more economicprosthesis fitting process. The method and apparatus of the presentinvention reduce the cost of fitting a new or replacement prostheticsocket, as well as for adjusting existing prosthetic sockets, andachieve comfort for the patient much more quickly.

In a particularly preferred embodiment, a plurality of temperature andpressure sensors are provided on the socket surface for collecting bothtemperature and pressure data relating to the engagement between thesocket and the stump. The use of both temperature and pressure sensorsin the stump allows an improved understanding of the engagement betweenthe stump and the socket to be formed, the temperature sensors providingnot only biometric information relating to the surface of the stump butalso allows temperature compensation of the pressure readings to becarried out, thereby improving their accuracy, as well as other benefitssuch as obtaining information about sensitive spots which are prone toulcers and injury.

The bio-sensors may be attached individually to the socket, it beingimportant primarily that the exact location of each sensor in thesocket, relative to a reference point, is known. Preferably, however,the bio-sensors are provided in strips or arrays, so that they may beapplied to the surface of the socket in a fixed relation to each other.This has the advantage of making the application process quicker whilstat the same time ensuring accurate spacing. Furthermore, by providingthe sensors in strips rather than in a web or net, the spacing betweenthe strips can be varied to control the density of the monitoring, sothat high resolution monitoring can be carried out in areas of greaterinterest, namely with respect to pressure or temperature variation. Anappropriate pattern of sensors on or in the strip may be used, such asalternating between pressure and temperature sensors, or indeed anyother bio-sensor capable of sensing and measuring a physiological orphysical variable of interest.

The bio-sensors used in the present system collect bio-data from theprosthesis socket in use. The bio-sensors are thin, preferably less than1 mm in thickness so that they themselves do not become a source ofdiscomfort for the user and have an impact on data acquisition. Suitablemodels are available from Interlink Electronics Inc. of California, USA,reference FSR400. This particular model can measure applied force from0.2N to 20 N and is particularly suited to pressure determinationbetween the stump and the socket. In addition, these bio-sensors canmeasure resistances from 45 Ω to 45MΩ and vary proportionally accordingto the force applied over the sensing area (19.635 mm² approximately).Other useful models include FSR400 Short from Interlink Electronics orHD-001 from IEE in Luxembourg.

Bio-sensors can also be temperature sensors, they too are mechanicaltransducers and are named Thermistors. Useful thermistor resistancesrange from 0.4 kΩ to 400 kΩ and they vary according to the temperatureto which they are exposed. Suitable sensors such as NTC JT Thermistors,specifically 103 JT-025 are produced by Semitec USA Corp (California,USA).

Depending on the variable of interest, different type of sensors may beused. The preferred embodiment includes a sandwich-type construction,the sensors being placed between two layers of material, which can bemade of any suitable polymer, flexible, thin film and be delivered inrolls. There can be one plastic film A comprising two sides A1 and A2,which can be coated with a bio-compatible material on side A1 which willbe in contact with the stump skin or a liner and which can be coatedwith an adhesive material on side A2 which will receive the sensors, aswell as the power and data leads thereof and hold them it in place.There can be another plastic film B also comprising two sides B1 and B2,which can be optionally coated with an adhesive material on side B1.Side B1 is intended to fit exactly over side A2 of strip A and therebysandwich the sensors and leads, and side B2 can be coated with anadhesive material or be composed of an adhesive material and it will beapplied and adhere to the socket.

This is in the case of the sensors being applied and adhering to thesocket. Other variations of the sensors may be built so that they adhereto the stump or the liner and surface finishes shall be modified to thatend.

Plastic film rolls A and B are substantially of the same width or about1.5 cm to 4 cm and several metres in length, for economic manufacturing;they can be cut later to proper length before use. They can be producedin a high-speed, continuous assembly line which will dispense and placethe sensors and power and data leads onto side A2 of film roll A. Theassembly line will then dispense and precisely place side B1 of filmroll B over side A2 of film roll A and press the two films together soas to create a strip of sandwiched sensors and leads. The continuoussensor strip is then cut at appropriate lengths ranging from about 10 cmto 50 cm to produce individual sensor strips for use. Individual sensorstrips, comprising one or more individual bio-sensors 819, 919, are theneach fitted with a power and data interface device which is glued,clamped or soldered at one of the extremities of the sensor strip toconnect with the power and data leads of the sensor, so as to providepower to the sensors and acquire data from them.

It should be noted that the arrangement and combination of surfaces andfinishes described above for all four sides of plastic film rolls A andB is not mandatory and that other constructions may be used, providedthe bio-sensors 819, 919 sensors are adequately held in place. Indeed,in a further embodiment the sensor strip could comprise a single plasticfilm strip, and the sensors and the leads could be treated with anadhesive finish on one side so that proper adhesion to the plastic filmwould be ensured by the sensors and leads themselves. In thisconstruction, the side of the plastic film facing the socket would havean adhesive finish and the other side facing the stump or liner wouldhave bio-compatible properties. The adhesive is “weak” so that thebio-sensor strip can be removed from one object and re-used on anotherobject. Processes to manufacture bio-sensors in strips or in rolls isachievable through existing know-how and equipment to the personsskilled in the art.

BRIEF DESCRIPTION OF THE DRAWINGS

In order that the invention may be well understood, there will now bedescribed some embodiments thereof, given by way of example, referencebeing made to the accompanying drawings, in which:

FIGS. 1A to 1E are a conceptual representation of the invention where itrelates to socket surface acquisition, measurement and rendering.

FIG. 2 is a view of the first aspect of the laser and camera system.

FIG. 3A is a section view of a second aspect of the laser and camerasystem.

FIG. 3B is a section view of a third aspect of the laser and camerasystem.

FIG. 4 is a representation of the laser plane and the camera field ofview of the first aspect.

FIG. 5A is a representation of the laser plane and the camera field ofview of the second aspect.

FIG. 5B is a representation of the laser plane and the camera field ofview of the third aspect.

FIG. 6 is a top view of the laser plane and the camera field of view ofthe first aspect.

FIG. 7A is a top view of the laser plane and the camera field of view ofthe second aspect.

FIG. 7B is a top view of the laser plane and the camera field of view ofthe third aspect.

FIGS. 8A, 8B and 8C are representations of the bio-sensors strip

FIG. 9 is a conceptual representation of the invention combining thebio-sensor data with the socket surface map, resulting in a superimposedbio-data and virtual socket surface map.

FIGS. 10A to 10F describe the invention in use, showing a prosthetictechnician and a patient with an amputated leg, where the technician isusing virtual reality vision system to better observe areas to adjust inthe socket.

FIGS. 11A to 11F describe the invention in use, showing a prosthetictechnician and a patient with an amputated leg, where the technician isusing an augmented reality device to better observe areas to adjust inthe socket.

FIGS. 12 and 13 show flow diagrams of the method

DETAILED DESCRIPTION OF THE INVENTION

The invention will now be described on the basis of the drawings. Itwill be understood that the embodiments and aspects of the inventiondescribed herein are only examples and do not limit the protective scopeof the claims in any way. The invention is defined by the claims andtheir equivalents. It will be understood that features of one aspect orembodiment of the invention can be combined with a feature of adifferent aspect or aspects and/or embodiments of the invention.

Referring first to FIGS. 1A to 1E, there is shown a summary of the stepsinvolved in mapping and modelling in three dimensions of a socket for anartificial limb. Reference is also made to FIGS. 2 to 4 which shows theapparatus used for the mapping and modelling of the socket in threedimensions. The description below assumes that a laser is used as theradiation source, but it will be appreciated that other beams of lightcould be used to scan the socket of the artificial limb and thisapplication is not limited to laser scanning.

FIG. 1A shows a projected laser line 101, as it is projected on thesurface of a scanned object. FIG. 1B shows the reference point 102 ofthe projected laser line 101. In this aspect, the projected laser line101 is substantially circular in form and the reference point is thecentre of the circle, as the centre is computed from data acquired byone or more cameras 411, 511 (see FIGS. 4, 5A and 5B) in a subsequentstep. It will be appreciated that the projected laser line 101 may notbe circular (or elliptical) in other aspects and, in this case, asuitable reference point needs to be found and used. FIG. 1C shows theprojected laser line 101 segmented into discrete data points 103following identification of the projected laser line 101 by the camera211. This results in a complete conversion of the projected laser line101 into a plurality of individual pixels 103, of which A, B and C arerepresentations. By knowing the resolution of the camera 411 and itsposition relative to the laser beam, by calculating the position of allof the plurality of the line pixels 103, by calibrating the system toinfer the real position of each point, the distance of each data point103 of the line 101 to the reference point 102 may be calculated, andthus position and spatial coordinates of the data points 103 can bedetermined. These data points 103 will also represent the actual surfaceof the scanned object.

In FIG. 1D, as the camera 211 and laser assembly move together inincremental steps along the z axis, scanning a new area of the socket,variations in the surface dimensions of the socket will result in acorresponding change in the projected laser line 104 a-g being projectedthereon. As the projected laser line acquisition, segmentation, pixelconversion and distance-to-reference point process is repeated acrossthe entire depth of the scanned object, this results in a plurality ofvirtual substantially projected laser lines 104, which are then joined,as shown in FIG. 1E, to generate a virtual surface map 106 of thescanned object. FIG. 1E also shows a circled x ⊗ 105 which representsorigin coordinates on the virtual surface map 106 of the scanned object.The circled x as the origin coordinates 105 will be used as a spatialreference point to allow correct alignment with the origin coordinates105 of a bio-data map at the final stage of the process.

In FIG. 2, there is shown a schematic illustration of a conical laserassembly 200 according to a first aspect of the invention. There is amoving support assembly 240 which supports a devices support frame 210and the devices support frame 210 moves with the moving support assembly240. The devices support frame 210 supports a camera 211, a laser device213 provided with a laser lens 214 and a conical mirror 215. The movingsupport assembly 240 is connected to a linear screw 208 by a bushing 209so as to be moveable towards and away (more frequently vertically) alongthe longitudinal axis of the scanned socket 216. The linear screw 208and moving support assembly 240 are secured to an anchor frame 239 whichwill be attached to a solid, immovable surface or point such as a wallor an appropriate apparatus housing. The linear screw 208 is attached toa motor 207 mounted on the anchor frame 239. The motor 207 rotates thelinear screw 208, leading to a movement of the bushing 209 andconsequently of all the moving support assembly 240 of all elements(210, 213, 211, 215) connected thereto.

The camera 211 is mounted above a single point laser device 213 whichprojects a conventional laser beam 236 onto a conical mirror 215. Thelaser 213 is arranged to focus the laser beam 236 on the vertex of theconical mirror 215, and the mirror surface of the conical mirror 215reflects the laser beam 236 outwards from the plane of the base of themirror 215 so as to project the laser line 201 extending from the planeof the base of the mirror 215. The scanned object, a prosthetic socket216, is mounted on a fixing base 217 which does not move so that thescanned object remains stationary. A physical origin coordinate 212,identified by a circled cross ⊕ and placed on the surface of the socket216 provides a spatial reference point which will be useful to orientand align the physical socket 216 with the virtual 3D model of thesocket 216 and with the 3D profile of the bio-data.

In use, the devices support frame 210 moves vertically, starting from atop position where the laser 213 focuses its laser beam 236 on theconical mirror 215 and begins to scan the top of the socket 216. A lineof laser light, the perimeter of which is represented by points line 201is projected on the internal area of the socket 216, whereupon theprocess previously described of laser line acquisition, segmentation,calibration, distance-to-reference point calculation and linecoordinates calculation is performed. These data are stored in acomputer (not shown) and the motor 207 turns the linear screw 208 whichin turn moves the moving support assembly 240 to the next incrementalposition, thereby lowering the devices support frame 210 one unit ofmovement (typically in increments of 5 mm, but this is not limiting ofthe invention). The entire process is repeated again in a new dataacquisition stage until the entire socket 216 internal surface isscanned and mapped. At the conclusion of the process the datacorresponding to each slice of socket surface is joined and a full 3Dmap of the lines is formed, thus rendering a virtual image of the socket216 as previously shown in FIG. 1F.

It will be inferred that there is a blind spot on socket 216 mappingcaused by the devices support frame 210, the arms of which will blockthe field of view of camera 211. In order to acquire the hidden pointson the socket 216 surface, this may be achieved by installing adecoupling mechanism (not shown) between the moving support assembly 240and the devices support frame 210, which will allow the support arms ofthe devices support frame 210 to rotate sufficiently, for the previouslyhidden portion of laser plane 201 to become visible to the camera 211while the camera 211 stays in the same position.

Strips of bio-sensors 219 are arranged on the inside of the socket 216and will record various biomedical parameters, as explained below. Thesebio-sensors 219 are described in more detail in connections with FIGS. 8and 9. Only two bio-sensors 219 are shown on FIG. 2 for simplicity, butin fact the inside surface of the socket 216 will have a much largernumber of bio-sensors 219. It will also be realised that the bio-sensors219 are shown much larger on this FIG. 2 than in real life, as thebio-sensors 219 should not affect the position of the limb in the socket216. The bio-sensors 219 have target or reference markings on their topsurface which are visible to the camera. A light source 220, such as anLED white light, illuminates the inside of the socket 216 and the camera211 records the position of the bio-sensors 219 using the markings. Thecamera 211 is moved along the vertical axis and several images arecaptured. The shape of the markings is known and thus the position ofthe bio-sensors 219 relative to the vertical axis can be determined. Itwould also be possible to take images under ambient light.

FIG. 3A shows a second aspect of the invention which overcomes the blindspot issue discussed above. This second aspect uses the same laser 313provided with a laser lens 314 which comprises a diffractive opticalelement 315. When the laser beam from the laser 313 is directed throughdiffractive optical element 315, the optical element 315 diffracts theprojected laser beam 337 and produces a projected solid laser line 301.This is projected outward onto the surface of the scanned socket 316,the diameter and contour of the projected laser line 301 being dependenton the surface of the scanned socket 316.

The laser 313 and the camera 311 are mounted on the device supportingframe 310 that is attached to a moving support assembly 340. The movingsupport assembly 340 is connected to a linear screw 308 by a bushing 309so as to be moveable towards and away (more frequently vertically) alongthe longitudinal axis of the scanned socket 316. The linear screw 308 isattached to the anchor frame 339 which will be attached to a solid,immovable surface or point such as a wall or an appropriatefloor-standing apparatus housing 341. The linear screw 308 will beattached to a motor 307, which will rotate the linear screw 308 leadingto a movement of the bushing 309 and consequently of the moving supportassembly 340 and of all elements (310, 313, 311, 315) connected thereto.

The capturing element in the form of the camera 311 is mounted in afixed position relative to the laser 313 but unlike the first aspectshown in FIG. 2, the camera 311 is slightly offset from the longitudinalaxis of the laser 313. The camera 311 thus moves with the laser 313towards and away along the longitudinal axis of the scanned socket 316.The scanned object, a prosthetic socket 316, is kept in place by afixing base 317, which does not move so that the prosthetic socket 316remains stationary during scanning. A physical origin coordinate 312,identified by a circled cross ⊕ and virtually placed or actually drawnon the surface of the prosthetic socket 316 provides a spatial referencepoint which will be useful to orient and align the physical prostheticsocket 316 with the virtual 3D model of the prosthetic socket 316 andwith the 3D model of the bio-data.

In use, the laser 313 and the camera 311 move together to scan and mapthe interior surface of socket 316. The optical element 315 diffractsthe laser light so as to produce a projected laser cone 301 on thesurface of the scanned socket 316, where the laser cone 301 isprojected, whereupon the process previously described of lineacquisition, segmentation, calibration, distance-to-reference pointcalculation and line coordinates calculation is performed. These dataare stored in a computer (not shown) and the motor 307 moves to the nextincremental position, thereby moving the devices support frame 310 oneunit of movement (typically but not limiting of the invention, 5 mm),and the entire process is repeated again until the entire socket 316surface is scanned and mapped. At the conclusion of the process the datacorresponding to each slice of socket surface is joined and a full 3Dmap of the lines is formed, thus rendering a virtual image of the socket316 as shown in FIG. 1F.

Unlike the first aspect shown in FIG. 2, the second aspect of FIG. 3Adoes not have obstacles on the path of the camera 311 or the projectedlaser line 301, and there are therefore substantially no hidden areas onthe socket 316 surface. It should be noted that data from any hiddenareas can be reconstructed mathematically.

A third aspect of the invention is shown in FIG. 3B which shows anarrangement with two (or more) cameras 311 positioned to the right andleft of the laser 313. The other elements depicted in FIG. 3B areotherwise identical with those of FIG. 3A. The arrangement shown in FIG.3B is able to scan more accurately the surface because more informationfrom the two cameras 311 is gained and a stereographic picture can beformed.

In FIG. 4, there is shown a schematic representation of the first aspectof the invention, comprising a camera 411, a field of view 418 and alaser plane 401, created by the reflection of the laser beam from thelaser 413 on the conic mirror 415. The camera field of view 418 has acentre C1, a length C3 and a width C2, so that the image which will becaptured will have C3×C2 pixels and this number of captured pixels willvary depending on camera resolution of the camera 411. The laser plane401 will have a variable shape depending on the surface and shape of thescanned object, e.g. the prosthesis socket 216 shown in FIG. 2. Whenscanning the socket 216, the laser plane 401 will project a circle oflaser light with a centre L1 of a shape which will most frequently beroughly elliptical. L3 and L4 are examples of the variable diameters ofthat elliptical shape. In this first aspect, the centre points C1 and L1are in the same x, y, and z position and will be considered to thereference point in this first aspect. By keeping a fixed distance L2between the camera 411 and the laser plane 401, it is possible todetermine a calibration rule that relates the dimension in pixels in thevirtual image to the dimension in millimetres of the real scanned object(e.g. socket 216) and with this rule calculate the position of eachpoint of the scanned object surface. By joining all these pointsacquired at each acquisition stage, a full model of the scanned objectmay be obtained.

In FIGS. 5A and 5B, there are shown a schematic representation of thesecond aspect and the third aspect of the invention. These FIGS. 5A and5B show a laser 513, a single camera 511 in FIG. 5A and two cameras 55in FIG. 5B, a diffractive optical element 515, a single camera field ofview 518 in FIG. 5A and two camera fields of view 518 in FIG. 5B and aprojected laser beam 501. The projected laser beam 501 produces apattern of know dimensions and shape. It could be for example, a cone ora grid pattern, but this is not limiting of the invention. It will benoted that the laser 513 and the camera(s) 511 are fixed in relation toeach other. The diffractive element 515 creates a laser plane 501 withan angular opening L5. The laser plane 501 has a variable shapeaccording to the scanned object shape and surface and the diffractiveelement 515. The camera field of view 518 depicted in FIG. 5A has areference axis C1, a length C3 and a width C2. The projected laser beamproduces a series of laser scans 501 along the reference axis will havea variable shape depending on the surface and shape of the scannedobject. When scanning the socket 316 of FIG. 3, each successive laserscan 501 be imaged as a two-dimensional image in the camera(s) 511 willagain have a reference point L1 on the reference axis and L3 and L4 areexamples of the points of the scan.

However, in this second aspect shown in FIG. 5A, camera field of viewreference point C1 and laser reference point L1 are in differentpositions and the distance D1 between the camera field of view referencepoint C1 and the laser plane reference point L1 is a function of thedistance between the reference axis of the laser 513 and the referenceaxis of the camera 511. The field of view reference point C1 will alwaysbe on the same longitudinally oriented reference axis of the camera insuccessive ones of the (two-dimensional) images taken at each of theimage acquisition stage. However, the laser plane reference point L1 inthe camera field of view will vary as the surface of the scanned object316 approaches the camera 511 or moves away from the camera 511. For agiven point of the projection of the laser beam on the scanned object316, it is possible to define a line of view from the point ofprojection to the camera(s) 511. The world coordinates of this givenpoint will be the intersection of this line of view from the camera(s)511 to the projected laser pattern. These variable distances and thechanging of the laser reference point L1 require appropriatecalculation, calibration and dynamic calibration methods, to relate thevirtual dimensions of each of the series of images acquired by thecamera 511 with the real dimensions in millimetres of the scanned objectsurface upon which the projected laser beam 501 is projected and thus todetermine with precision the correct coordinates of each point of theprojected laser beam 501 and therefore the correct surface measurementof the scanned object 316. This variable value of distance D1 onlyoccurs in the images (virtual D1). In reality, the distance between thereference axis of the laser 513 and the reference axis of the camera 511(real D1) is always substantially the same, thus allowing to compute thedynamic calibration method.

Similar issues occur with the third aspect of the invention shown inFIG. 3B, which includes two cameras 311. The third aspect is differentfrom the second aspect in the sense that the two (or indeed more)cameras 311 require a variation of the method for achieving the 3Dreconstruction. As described with respect to the first and secondaspects, the cameras 311 and laser 313 are moved along the vertical axisand the projected laser beam 337 is captured by both of the cameras 311.This capture can be simultaneously performed or statically.

The relative orientation/position and origin of the field of views ofthe cameras 311 is known and thus by identifying a given physicalreference (i.e. a point 301 of the projected laser beam) in the capturedimage by both cameras 311, it is possible to infer the relative positionof the point 301 of the projected laser beam 337 to the reference axis.The reference axis has an origin between the cameras 311. This samephysical reference of the point 301 captured by both of the cameras 311is represent by different pairs of pixels in the two-dimensional imagestaken by the cameras 311 and it is this difference combined with theposition and orientation between cameras 311 that enables thecalculation of the three-dimensional position of the points 310on theprojected laser beam 337.

To find the relative position between both of the cameras 311 (afterbeing placed in the camera mount), several images of a given referencefigure should be captured simultaneously by both cameras 311, atdifferent distances and orientation to the cameras 311. For example, thegiven reference figure could be a chessboard, but this is not limitingof the invention. By identifying key-points in this reference figure inboth of the captured images (either by manually picking or automaticprocessing) and previously knowing their real/physical distances betweenkey points in the reference figure, it is possible to mathematicallydetermine the relative position between the field of view of both of thecameras 311.

Both the sockets 316 in FIGS. 3A and 3B have bio-sensors 319 asexplained in connection with FIG. 2. A light source 320 illuminates thebio-sensors 319 and the camera(s) 311 record the position of thebio-sensors 319. In the case of FIG. 3B, there are two light sources320.

FIG. 6 illustrates a top view of the first aspect, comprising the camera611 and the laser 613, and their respective longitudinal axes arealigned along the same axis. The laser plane 601 is centred and insidethe camera field of view 618.

FIG. 7A shows a top view of the camera 711 and the laser 713 in thesecond aspect, showing the two devices, the camera 711 and the laser 713to be placed no longer along the same axis, but offset from each other,resulting in the centre of laser plane 701 to be different from thereference axis, i.e. centre of camera field of view 718. Similarly, FIG.5B shows the same top view of the third aspect of the invention with twocameras 711.

It will be appreciated that the use of the two cameras 311, 511, 711 inthe third aspect of the invention means that both cameras 311, 511, 711need to be calibrated in order to know the precise relative position andpose between the two cameras 311, 511, 711 and the lens distortion ineach of the two cameras. These parameters are always different due tomanufacturing variability.

To calibrate the cameras 311, 511, 711 and to compensate for differencein the lens parameters of the cameras 311, 511 and 711, a method basedon Zhang. “A Flexible New Technique for Camera Calibration” published inIEEE Transactions on Pattern Analysis and Machine Intelligence,22(11):1330-1334, 2000, is used. This method requires a custom-designedcamera mount which holds both cameras 311, 511, 711 and the laser 313,513, 713 i.e. the same laser that will be used in the laser scannersystem. In the calibration, a chessboard design placed in a flat surfaceis used as a reference figure. The dimensions of the squares of thechessboard is known. A number of pictures are taken simultaneously fromboth of the cameras 311, 511, 711 in which the chessboard is placed atdifferent distances to the cameras 311, 511, 711 and at differentorientations.

The corners of the chessboard of every pair of images taken from thecameras 311, 511, 711 are detected. The number of squares of thechessboard are known and thus it is simple to match the corners detectedby both of the stereo images taken from the two cameras 311, 511, 711.The chessboard plane is considered to be at z=0, only leaving theproblem to be solved only in this plane (with origin in one of thecorners of the chessboard).

Each of the images is automatically processed in order to find thechessboard patterns, acquiring one conversion from the image cornerpixels to the real 3D positions of the chessboard. This enables thecomputation of the intrinsic lens parameters for each of the cameras311, 511, 711 (i.e. distortion coefficients), by trying to minimize the2D<->3D re-projection error in all images. After carrying out thiscalculation, it is possible to use these 2D-3D correspondences tocalculate the transformation matrix between the images from the twocameras 311, 511, 711.

This calibration enables the computation of the matrix which projectsthe images of both cameras 311, 511, 711 onto a common image plane,i.e., to rectify the images. This process makes it easier to findcorrespondences between the stereo images because the process aligns theimage in such a way that theoretically it is only necessary to searchalong a single line (if the calibration is accurate, correspondentpoints are in the same row of the rectified images). After constructingthe undistorted and coplanar image planes, the 3D reconstruction can beachieved by triangulation.

FIGS. 8A to 8C now illustrate the bio-sensors. FIG. 8A shows a top viewof bio-sensor strip 821 comprising bio-sensors 819 and power and dataleads 820, which in turn connect to a power and data connector 823,itself connected to a transmitting device 822 that can be connected,preferably wirelessly, to a computer or handheld mobile smart device(not shown).

FIG. 8B shows a section view of the bio-sensor strip of FIG. 8A,comprising two strips of plastic film 824 and 825, which sandwich thebio-sensors 819. In one aspect, the bio-sensor 819 are pressure sensors,but as noted elsewhere, other types of sensors can be used. Thebio-sensor comprises a pressure-sensitive resistor which resistancechanges depending on the load or pressure applied to the bio-sensor 819.Measurement of the change of resistance is carried out using a bridgecircuit.

The power leads and data leads 820 made, for example, of silver ink arenot illustrated in this FIG. 8B. Side A1 of plastic film 824 will be incontact with the stump skin, i.e. the skin on the residual limb, or theliner covering the residual limb, and will preferably have abio-compatible finish. A non-limiting example of the bio-compatiblefinish is polyurethane. Side A2 of the plastic film 824 faces thebio-sensors 819 and holds the bio-sensors 819 in place. Preferably, theside A2 has an adhesive finish from, for example, a medical gradeacrylic adhesive, so that the bio-sensors 819 do not move.

Side B1 of polymer film 825 on FIG. 8B faces the bio-sensors 819 andholds the bio-sensors 819 in place. The side B1 may have an adhesivefinish, e.g. from a medical grade acrylic adhesive, so that bio-sensors819 do not move. The side B2 of the plastic film 825 is, for example,silicone and will be in contact with the prosthetic socket surface ofthe prosthetic surface 216, 316 (not shown in FIG. 8B). The side B2 willpreferably have an adhesive finish, so that the bio-sensor strip 819 isfirmly held in place on the socket surface.

The side A1 of the plastic film 824 will have one or more markings 830on the surface. These markings are illuminated by the light source 220,320 to locate the bio-sensors on the inside of the socket 216, 316 asexplained previously. In one non-limiting aspect, the markings aremulti-coloured roundels (concentric circles). The different colours areused to indicate differing positions or the different types ofbio-sensors within the socket 216, 316. Currently, at least two markingsper strip are required to uniquely identify the position of thebio-sensor strip 819, but a single marking could be acceptable.

FIG. 8C shows a section view of a simpler embodiment of the bio-sensorstrip 819, comprising a single plastic film 825, to which thebio-sensors 819 with an adhesive finish 826 are applied to the B1 sideof the plastic film 825. This side B1 faces the stump skin and has abio-compatible finish, while side B2 of plastic film 825 will be incontact with the prosthetic socket surface of the prosthetic socket 216,316 and will preferably have an adhesive finish, so that the bio-sensorstrip 819 is firmly held in place on the socket surface. It will beappreciated that the sides B1 and B2 could be reversed so that B2 is incontact with the stump skin.

Before use, the bio-sensor strips 819 are covered on the adhesive sidewith a peelable cover if dispensed in pre-cut strips, or not covered ifthey are dispensed in rolls. In use, the peelable covers are removed,the bio-sensor strips 820 are cut to the right size, if needed, and thebio-sensor strips 820 are applied to the internal surface of theprosthetic socket 216, 316, in the orientation best determined by theprosthetic fitting technician's experience.

The biosensor strips 819 can measure different types of biodata, whichinclude but are not limit to pressure between the stump skin and theprosthetic socket surface, or temperature. In one non-limiting example,the biosensor strips are formed of a force sensing resistor comprisingat least one polymer layer whose resistance varies on application of apressure. The change in the resistance can be measured, for example, bya bridge circuit. In one aspect of the bio-sensor a plurality of polymerlayers is used with different characteristics to allow a wide range ofdifferent pressures to be measured.

FIG. 9 shows the elements of the complete system of the presentinvention. The bio-sensor strip 921 comprising the bio-sensors 919acquires the bio-data which is transmitted to a computer, a hand-helddevice or similar data processing device 927. The bio-sensor strips 921are applied to an internal surface of the prosthetic socket 916,resulting in a sensorized socket 928, which will receive a residualstump 932 of the residual limb. The bio-sensor strips 921 are positionedin relation to the real origin coordinate 912, which is known or whichcan be automatically determined by the light source 220, 320 scanningsystem as shown and described with respect to FIGS. 2 and 3. The datafrom each of the bio-sensors 919 can be overlaid on the socket surfacemap 906 generated by the light source scanning system by using acomputing device 927, resulting in a 3D bio-data profile 930. The 3Dbio-data profile 930 can be oriented by relating the virtual origincoordinate 905 with the real origin coordinate 912, allowing theaccurate representation of the bio-data profile 929 with the socketsurface map 906.

Furthermore, the spacing between the bio-sensor strips 921 can beadjusted to vary the resolution of the data obtained the bio-sensorstrips 921 can be arranged closer together or even on top of each otherwith an offset in areas where greater data resolution is required. Whenevaluating pressure, a correct fit between the stump 932 and the socket916 will produce uniform pressure distribution across certain areas ofthe surface of the socket 916, depending on the socket type, while apoor fit will produce areas of altered pressure which will be evidencedby more concentrated curves in the bio-data profile 929, in zones wherethis should not occur.

It will be appreciated that absolute values from the bio-sensors are notrequired. The values can be normalised or otherwise mathematicallymanipulated with respect to the maximum value recorded.

Artificial colour may be added to the bio-data profile 929 to create aheat map and thus illustrate the areas of pressure. Shifts in the colourmay be used to differentiate between areas of equally uncomfortableareas of increased or reduced pressure, such as red for higher pressure,and blue for lower pressure. The prosthesis technician can thereforeidentify high pressure areas of the socket 916 which need fine tuningand shaping back as well as areas of lower pressure which indicateregions of the socket 916 which need building up. Other types ofbio-data of interest may be represented using the same method.

The arrangement of the bio-sensors 919 on the bio-sensor strips 921enables the system to be wearable, non-invasive, autonomous (with longbattery time), modular, flexible (with different placement of sensors),scalable (more sensors as needed), and versatile (different type ofmodules/sensors).

The images of the bio-sensor strips 921 are drawn on the surface of thestump 932 to indicate their location in relation to the stump 932. Thereal origin coordinates 912 are actually or virtually drawn on thescanned socket 916 and the scanning and data acquisition apparatusproduces the 3D image of the scanned socket 906.

An example can serve to illustrate this in more detail. Suppose theprosthesis is an artificial leg or an artificial arm. In use, thepatient with the artificial leg is made to walk (in the case of a leg)or move (in case of an artificial arm) for a certain amount of timeuntil sufficient bio-sensor data has been obtained from the bio-sensors919 to produce the virtual 3D bio-data profile 930 comprising bio-dataprofile curves 929 of the pressure, temperature or any other bio-data ofinterest. The position of these bio-data profile curves 929 is known byreference to virtual origin coordinates 905 of the 3D bio-data profile930.

It is also possible to combine the bio-sensor data with data from one ofmore inertial motion units which is carried by the patient and attachedto the limb. The inertial motion unit will have three, six or nine axesand provide information about the changes in the data as the patientmoves. This data can be used to characterise potential gait anomalies.

FIGS. 10A-C shows the fitting of a prosthetic leg using the componentsof the present invention, using a virtual reality or augmented realityvision system.

FIG. 10A shows a prosthesis fitting technician using a virtual realityor augmented reality vision system 1031 and the residual member 1032 ofa user. It will be noted that some residual members 1032 are coveredwith liners or socks, part of which is shown as 1033 on the figure.

FIG. 10B shows what the prosthesis fitting technician sees through thevirtual reality or augmented reality vision system 1031, whichsuperimposes the 3D surface map 1006 of the socket 916, which has beenobtained by the scanning, imaging and surface determination system ofthe present invention, with the virtual origin coordinate point 1005 ofthe socket 916, themselves precisely aligned with the user's residuallimb 1032, in the same limb location where the socket 916 was wornduring the testing and data acquisition phase (walking, moving). Thisallows the prosthesis fitting technician to correctly identify theproblematic areas of the socket 916.

Furthermore, a light grid may be projected onto the patient's stump orover the surface of the actual socket 916 which is calibrated to the 3Dsocket model so as to help the prosthetic fitting technician tocorrelate the 3D image with the actual socket surface of the socket 916and hence help identify the areas that need adjustment on the actualsocket surface.

FIG. 10C shows the same image as FIG. 10B, but now the virtual realityor augmented reality vision system 1031 of the present disclosure addsthe layer of the bio-data profile 1030 and the bio-data profile maps1029 to FIG. 10B. At the virtual origin coordinate point 1005 twovirtual origin coordinate points are precisely superimposed: the originpoint of the 3D socket surface map 1006 and the origin point of thebio-data profile 1030, both precisely aligned with the same limblocation where the socket 916 was worn during testing. The alignment ofall of these origin coordinate points is needed so that bio-dataobtained actually matches the appropriate area of the physical socket916 and the corresponding area of the residual limb 1032 location.

The purpose of the layering of the various data maps is to evidence theareas where pressure, temperature or other data are more intense, andwhich may indicate areas of pain or discomfort for the person wearingthe prosthesis, or less intense which may indicate areas which lacksupport.

In FIG. 10D, the prosthetic fitting technician is now shown holding thesocket 1016 and a shaping tool 1038. The prosthetic fitting technicianwill now begin to shape the socket 1016, using the virtual reality oraugmented reality vision system 1031, which is able to correctly displayall of the data obtained by the virtual reality vision system 1031 andto referencing the data to the physical socket 1016 by identifying thereal origin coordinate point 1012 on the socket 1016.

FIG. 10E shows the visualization of the 3D socket surface map 1006 overthe actual prosthetic socket 1016, using the virtual reality oraugmented reality vision system 1031. This displays the information ofthe 3D socket surface map 1006 over the corresponding zones of theprosthetic socket 1016, which can be achieved by using the virtualorigin coordinate 1005.

FIG. 10F shows the visualization of the 3D bio-data profile 1030 overthe physical prosthetic socket 1016, using the virtual reality visionsystem 1031. The display of the information of the 3D bio-data profile1030 is overlaid onto the corresponding zones of the prosthetic socket1016, which can be achieved using the virtual origin coordinate 1005 ofthree data sets (bio-data profile curves, socket surface model andphysical stump) and overlapping the bio-data profile curves 1029 overthe surface map 1006, allowing the prosthetics fitting technician tocorrectly and quickly identify the areas that require adjustment.

FIG. 11 shows a similar process to that described in FIGS. 10A-F, butnow the prosthetics fitting technician is using an augmented realitydevice, such as a portable smart tablet equipped with augmented realitysoftware and appropriate rendering and layering software. This avoidsusing the cumbersome virtual reality vision system and allows thetechnician to observe all of the necessary information on the sameplane.

In FIG. 11A shows the prosthetic fitting technician using a handhelddevice 1134, such as a tablet or any other mobile device, mounted on aflexible arm support 1135 fixed to a solid surface such as a wall ortable (not shown) to examine the patient's residual limb 1132.

FIG. 11B shows the image as seen by the technician of the socket surfacemap 1106 superimposed over the amputee residual limb 1132, using thehandheld device 1134. This handheld device 1134 displays the informationof the socket surface map 1106 over the corresponding zones of theresidual limb 1132. Both images are aligned by means of both the virtualsocket origin coordinate 1105 and the real stump origin coordinate 1112.

FIG. 11C now adds to the handheld device's display 1134 thevisualization of the 3D bio-data profile 1130 over the amputee residuallimb 1132, using the handheld device 1134. This displays the informationof the 3D bio-data profile 1130 over the corresponding zones of theresidual limb 1132, which can be achieved using both the virtual socketorigin coordinate 1105 and the real stump origin coordinate 1112, andoverlapping the bio-data profile curves 1129 over the socket surface map1106, allowing the prosthetics fitting technician to correctly andeasily identify the problematic areas and to shape the problematicareas.

In FIG. 11D, the prosthetics fitting technician goes to work with ashaping tool 1138 on the socket 1116 which is observed by means of thehandheld device 1134 mounted on a flexible arm support 1135 and which isoriented by means of the real origin coordinate 1112.

FIG. 11E shows the image as seen by the technician of the surface map1106 over the prosthetic socket 1116, using the handheld device 1134.This handheld device 1134 displays the information of the surface map1106 over the corresponding zones of the physical prosthetic socket1116, which can be achieved using both the virtual origin coordinate1105 and the real origin coordinate 1112.

FIG. 11F now adds to the handheld device's display 1134 visualization ofthe 3D bio-data profile 1130 over the prosthetic socket 1116, using ahandheld device 1134. This displays the information of the 3D bio-dataprofile 1130 over the corresponding zones of the prosthetic socket 1116,which can be achieved using both the virtual origin coordinate 1105 andthe real origin coordinate 1112, and overlapping the data profile curves1129 over the surface map 1106, allowing the prosthetics fittingtechnician to correctly and quickly identify the problematic areas.

The alignment of the socket surface map 1106 and/or the 3D bio-dataprofile 1130 over the object of interest can be achieved by using thesame origin coordinate in the real object (real origin coordinate 1112),in the socket surface map 1106 (virtual origin coordinate 1105) and inthe 3D bio-data profile 1130 (virtual origin coordinate 1105), or byresorting to a best match algorithm, that computes the best geometricalmatch between two 3-dimensional objects.

The method will now be described with respect to the flow diagrams shownin FIGS. 12 and 13. The method starts at step 1200 and the object 216,316, for example the prosthesis 932, is scanned in step 1205. Aplurality of the biosensors 919 are attached to either the surface ofthe object 216, 316 or the body part, for example the stump 919, in step1210. The object 216, 316 is subsequently engaged with the body part 919in step 1215 and data is collected in step 1220 from the bio sensors919. The collected data is processed in step 1222 and superimposed instep 1225 over the surface map 1006 of the object 216, 316 to identifiedareas of the object 216, 316 that need to be adjusted. The superimposeddata on the surface map 1006 is displayed as a 3D model to the user, forexample the prosthetics fitting technician, in step 1227 beforeadjustments are made in step 1230.

The method for creating the surface map is shown in FIG. 13 which startswith scanning the object 216, 316 in step 1300 using a laser 213, 313projecting a laser line 201, 301 on the surface of the object 216, 316.An image of the object 216, 316 with the laser line 201, 301 is taken instep 1310 and the image data analyses in step 1315. If all of the object216, 316 has been scanned in step 1320, then the method is completed instep 1330 and the surface map of the object 216, 316 is created.Alternatively, the distance between the laser and the object 216, 316 ismoved to scan a different part of the object 216, 316 in step 1325.

The present invention comprising the use of the bio-sensors, the mappingof the internal surface of the prosthetic socket, the generation ofbio-data related to socket/stump fit and the identification of socketareas which require adjustment represents several economic and comfortbenefits. The method is non-invasive, unobtrusive and does not require aclinician's attendance. It saves considerable time in the fittingprocess, thereby reducing cost and increasing the patient's quality oflife.

REFERENCE NUMERALS

-   101 Laser Line-   102 Centre-   103 Data Points-   104 Laser line-   105 Origin coordinates-   106 Surface map-   200 Conical laser assembly-   201 Projected radiation line-   207 Motor-   208 Linear screw-   209 Bushing-   210 Support frame-   211 Camera-   212 Physical origin coordinate-   213 Laser-   214 Laser lens-   215 Conical mirror-   216 Socket-   217 Fixing base-   219 Bio-Sensors-   220 Radiation source-   236 Radiation beam-   239 Anchor frame-   240 Support assembly-   241 Wall or housing-   300 Conical laser assembly-   301 Projected radiation pattern-   307 Motor-   308 Linear screw-   309 Bushing-   310 Device supporting frame-   311 Camera-   312 Original coordinate-   313 Laser-   314 Laser lens-   315 Optical element-   316 Scanned socket-   317 Fixing base-   319 Bio-sensors-   320 Radiation source-   339 Anchor frame-   340 Support Assembly-   341 Wall or housing-   401 Laser Plane-   411 Camera-   413 Laser-   415 Conic mirror-   418 Field of view-   501 Laser plane-   511 Camera-   513 Laser-   515 Optical Element-   518 Field of view-   601 Laser plane-   611 Camera-   613 Laser-   618 Field of view-   701 Laser plane-   711 Camera-   713 Laser-   719 Field of view-   819 Bio-sensors-   820 Data Leads-   821 Bio-sensor strip-   822 Transmitting device-   823 Power and data connector-   824 Plastic film-   825 Plastic film-   826 Adhesive finish-   830 Markings-   905 Virtual original coordinates-   906 Socket surface map-   912 Real origin coordinate-   916 Prosthetic socket-   919 Bio-sensors-   921 Bio-sensor strip-   927 Data processing device-   928 Sensorised socket-   929 Curves-   930 Bio data profile-   932 Stump-   1005 Virtual origin coordinate point-   1006 3D surface map-   1016 Socket-   1029 Bio-data profile maps-   1030 Bio-data profile-   1031 Virtual reality vision system-   1032 Residual member-   1033 Liner or sock-   1038 Shaping tools-   1105 Virtual origin coordinate point-   1106 Socket surface map-   1112 Real sump origin coordinate-   1129 Bio-data profile curves-   1130 Bio-data profile-   1132 Residual limb-   1134 Handheld device-   1135 Support-   1138 Shaping tool

1. A bio-sensor strip adapted to be located between an object and a body part and comprising: one or more bio-sensors disposed on at least one first polymer film, wherein the one or more bio-sensors measure parameters at a location between the object and the body part; a plurality of power leads and data leads connected to the plurality of bio-sensors and to a power and data connector, wherein the plurality of data leads and the power and data connector are adapted to transfer data from the plurality of bio-sensors to a processor.
 2. The bio-sensor strip according to claim 1, wherein a body part liner is disposed between the bio-sensor strip and the body part (932).
 3. The bio-sensor strip according to claim 1, wherein a second polymer film is disposed on an opposite side of the one or more bio-sensors and the plurality of power leads and data leads.
 4. The bio-sensor strip of any of the above claims, wherein at least one of the first polymer film or the second polymer film has one or more markings disposed on one side, the one or more markings enabling determination of location of the bio-sensor strip.
 5. The bio-sensor strip according to claim 1, wherein a side of the bio-sensor strip in contact with the body part or the body part liner is made from polyurethane.
 6. The bio-sensor strip according to claim 1, wherein the one or more bio-sensors are affixed on the at least one first polymer film by an acrylic adhesive.
 7. The bio-sensor strip according to claim 1, wherein a side of the bio-sensor strip in contact with the object is made from silicone.
 8. The bio-sensor strip according to claim 1, wherein the one or more bio-sensors (819, 919) measure at least one of pressure between the body part (932) and the object (216, 316, 916), or temperature at the location.
 9. The bio-sensor strip according to claim 1, wherein the one or more bio-sensors (819, 919) measure at least one of a pulse or a galvanic response.
 10. The bio-sensor strip according to claim 1, wherein the one or more bio-sensors (819, 919) are arranged in a two-dimensional array.
 11. A method of evaluating properties between a body part and an object comprising: affixing one or more the bio-sensor strips of claim 1 to one of the body part or the object; collecting data from the one or more bio-sensor strips; and processing the data from the one or more bio-sensor strips to produce a heat map of the properties between the body part and the object.
 12. The method according to claim 11, wherein properties are indicative of at least one of fit, interaction or dynamics between the body part and the object.
 13. The method according to claim 11, wherein the recording of the data from the one or more bio-sensor strips is carried out whilst the body part is in motion.
 14. The method according to claim 11, further comprising collecting data from a motion sensor and correlating the data from the motion sensor with the data from the one or more bio-sensor strips. 